The Recall Desk
HighFDA (Devices)·Z-0796-2013·Announced 2013-02-13

Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

Custom Healthcare Systems is recalling 80 breast biopsy trays because they may contain particulate matter in the pharmaceuticals used for injection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (injection particulate matter) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Custom Healthcare Systems, Inc. is recalling 80 units of the Custom Breast Biopsy Tray, Catalog # B 9-16261. The product is a sterile medical device containing multiple components utilized by physicians to perform a breast biopsy. The recall is due to the possibility that the surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.

The affected product is identified by Lot No. 100212 and has an expiration date of 06/2013. The trays are packaged in bags, with 1 tray per bag and 20 bags per case. The product was distributed nationwide in the United States, including the states of Georgia, Ohio, North Carolina, and Maine.

Consumers and healthcare facilities should stop using the affected trays and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Manufacturer
Custom Healthcare Systems, Inc.
Category
Medical Device — Surgical Trays
Hazard
Affected units
80

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • LOT NO. 100212 EXPIRES: 06/2013

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Custom Healthcare Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Custom Healthcare Systems, Inc.

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Same hazard · particulate matter

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